Pain, ChronicProMPTNCT03962491
Mobile-Based Contingency Management to Promote Daily Self-monitoring in Primary Care Patients
A study testing Daily Self-Monitoring Surveys + Contingency Management and Daily Self-Monitoring Surveys in people with Pain, Chronic, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This project examines the efficacy and feasibility of contingency management (CM), delivered using a novel, fully automated CM app (DynamiCare Rewards), to promote daily self-monitoring of pain symptom severity and related variables (e.g., mood, sleep), as well as Rx opioid, alcohol, marijuana, cannabidiol (CBD), and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Daily Self-Monitoring Surveys + Contingency Management and Daily Self-Monitoring Surveys
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2020to 14 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age;
- own a study-compatible smartphone (iPhone or Android device);
- report non-cancer related chronic pain (consistent daily pain) for 3 months or greater;
- able to provide informed consent for study participation;
- used prescription opioids in the past 30 days; and
- having ever been prescribed 1 or more opioid medication(s) for pain management.
Who cannot join
- currently pregnant;
- presenting with language barriers, cognitive impairment, or serious medical or psychiatric illness that in the opinion of the Investigator would preclude them from providing informed consent or participating in the study; and
- visual impairment or motor impairment that would interfere with use of a smartphone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Using Mobile-based Contingency Management to Promote Daily Self-monitoring of Pain Severity and Prescription Opioid Use in a Primary Care Sample of Chronic Pain Patients
This project examines the efficacy and feasibility of contingency management (CM), delivered using a novel, fully automated CM app (DynamiCare Rewards), to promote daily self-monitoring of pain symptom severity and related variables (e.g., mood, sleep), as well as Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use in a sample of chronic pain patients. The project will conduct a 2-arm randomized clinical trial (RCT) comparing those receiving reinforcement escalating with continuous performance of the target behavior (CM group) vs those asked to complete the survey but will not be incentivized (C group).
Read the detailed description
Prescription (Rx) opioid misuse is a significant public health problem and the CDC has declared an opioid epidemic (Dowell, Haegerich, \& Chou, 2016). Chronic pain patients, often prescribed opioids for pain management, represent a particularly vulnerable population (e.g., Boscarino et al., 2011). Responsible opioid prescribing depends on effective identification of misuse and comprehensive understanding of pain-related variables (Dowell, Haegerich, \& Chou, 2016). Self-report tracking via smartphone apps is a promising solution, but difficulties with adherence have been found to impede the use of remote self-monitoring among chronic pain patients (e.g., Jamison et al., 2016), even with the inclusion of non-monetary rewards (Jamison et al., 2017). One robust strategy for improving adherence is contingency management (CM). While CM has been widely used in research, the translation to clinical practice has met with resistance due, in large part, to practical barriers (e.g., Carroll, 2014).
As a Stage 1 behavioral therapies development project (Rounsaville et al., 2001), the goal of this study is to examine the efficacy and feasibility of CM, delivered using a novel, fully automated CM app (DynamiCare), to promote daily self-monitoring of pain symptom severity and related variables (e.g., mood, sleep), as well as Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use in a sample of chronic pain patients. The target behavior will be objectively defined as completing daily self-monitoring surveys via the app for which those randomized to CM will earn incentives.
Participants will complete baseline assessment, followed by random assignment to either the experimental (CM) or control (C) group. All participants will then download the app onto their smartphone and be provided with instruction in its use. Based on the work by Petry et al. (2005) and Olmstead and Petry (2009), the CM group will receive reinforcement escalating with continuous performance of the target behavior while the C group will be asked to complete the survey, but will not receive incentivizes. Both groups will receive reminders to complete the daily survey. Follow-up assessments (including behavioral and psychological measures) will occur at intervention completion (28-days post-randomization) and both CM and C group members will be compensated for their time and effort.
The specific aims of this project are to: 1) Compare number of completed daily self-monitoring surveys in CM and C groups; 2) Compare longest sustained period of daily survey completion in CM and C groups; 3) Examine agreement between daily survey and 28-day follow-up visit reports of Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use in CM and C groups; 4) Examine feasibility and acceptability of CM app implementation targeting self-monitoring of pain severity, related factors, and Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use; and 5) Estimate effect-size to be used to perform power analyses and sample size calculations as part of the design of a larger RCT.
- Conditions
- Pain, Chronic
- Being tested
- Daily Self-Monitoring Surveys + Contingency Management, Daily Self-Monitoring Surveys
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Self-Monitoring Surveys + Contingency ManagementBehavioural
Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys.
Daily Self-Monitoring SurveysBehavioural
Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app.
| Study group | Role | What they receive |
|---|---|---|
| Daily Self-Monitoring Surveys | Other | Asked to complete daily self-monitoring surveys. Receives: Behavioral: Daily Self-Monitoring Surveys |
| Daily Self-Monitoring Surveys + Contingency Management | Experimental | Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards. Receives: Behavioral: Daily Self-Monitoring Surveys + Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Daily Self-monitoring Surveys Completed
Number of days daily surveys completed
Measured: 28-day daily survey period
Longest Period of Sustained Adherence to Daily Survey Completion
Largest number of consecutive days wherein daily surveys were completed
Measured: 28-day daily survey period
Secondary outcomes (2)
Daily Survey Completion Time
Mean time to complete daily surveys
Measured: 28-day daily survey period
CM App Acceptability
CM App Acceptability was measured using a 8 item scale asking about experiences using the app. Each item was rated on a 0 - 10 Likert scale with higher scores indicating more positive responses. Scores for each item are reported separately.
Measured: 28-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start24 Jan 2020
- Primary completion14 Apr 2021
- Study completion14 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Dace Svikis, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962491
- Sponsor's protocol ID
- HM20013828
- Other IDs
- 1R36DA046671
- Acronym
- ProMPT
- Status last verified
- Nov 2022
- First submitted
- 22 May 2019
- Last updated
- 7 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mobile-based Contingency Management to Promote Daily Self-monitoring of Pain Severity and Prescription Opioid Use in a Primary Care Sample of Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT03962491
- Acronym / sponsor ID
- ProMPT / HM20013828
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Posted 7 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project examines the efficacy and feasibility of contingency management (CM), delivered using a novel, fully automated CM app (DynamiCare Rewards), to promote daily self-monitoring of pain symptom severity and related variables (e.g., mood, sleep), as well as Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use in a sample of chronic pain patients. The project will conduct a 2-arm randomized clinical trial (RCT) comparing those receiving reinforcement escalating with continuous performance of the target behavior (CM group) vs those asked to complete the survey but will not be incentivized (C group).
Detailed description
Prescription (Rx) opioid misuse is a significant public health problem and the CDC has declared an opioid epidemic (Dowell, Haegerich, \& Chou, 2016). Chronic pain patients, often prescribed opioids for pain management, represent a particularly vulnerable population (e.g., Boscarino et al., 2011). Responsible opioid prescribing depends on effective identification of misuse and comprehensive understanding of pain-related variables (Dowell, Haegerich, \& Chou, 2016). Self-report tracking via smartphone apps is a promising solution, but difficulties with adherence have been found to impede the use of remote self-monitoring among chronic pain patients (e.g., Jamison et al., 2016), even with the inclusion of non-monetary rewards (Jamison et al., 2017). One robust strategy for improving adherence is contingency management (CM). While CM has been widely used in research, the translation to clinical practice has met with resistance due, in large part, to practical barriers (e.g., Carroll, 2014).
As a Stage 1 behavioral therapies development project (Rounsaville et al., 2001), the goal of this study is to examine the efficacy and feasibility of CM, delivered using a novel, fully automated CM app (DynamiCare), to promote daily self-monitoring of pain symptom severity and related variables (e.g., mood, sleep), as well as Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use in a sample of chronic pain patients. The target behavior will be objectively defined as completing daily self-monitoring surveys via the app for which those randomized to CM will earn incentives.
Participants will complete baseline assessment, followed by random assignment to either the experimental (CM) or control (C) group. All participants will then download the app onto their smartphone and be provided with instruction in its use. Based on the work by Petry et al. (2005) and Olmstead and Petry (2009), the CM group will receive reinforcement escalating with continuous performance of the target behavior while the C group will be asked to complete the survey, but will not receive incentivizes. Both groups will receive reminders to complete the daily survey. Follow-up assessments (including behavioral and psychological measures) will occur at intervention completion (28-days post-randomization) and both CM and C group members will be compensated for their time and effort.
The specific aims of this project are to: 1) Compare number of completed daily self-monitoring surveys in CM and C groups; 2) Compare longest sustained period of daily survey completion in CM and C groups; 3) Examine agreement between daily survey and 28-day follow-up visit reports of Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use in CM and C groups; 4) Examine feasibility and acceptability of CM app implementation targeting self-monitoring of pain severity, related factors, and Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use; and 5) Estimate effect-size to be used to perform power analyses and sample size calculations as part of the design of a larger RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Self-Monitoring Surveys | Other | Behavioral: Daily Self-Monitoring SurveysAsked to complete daily self-monitoring surveys. |
| Daily Self-Monitoring Surveys + Contingency Management | Experimental | Behavioral: Daily Self-Monitoring Surveys + Contingency ManagementAsked to complete daily self-monitoring surveys, with opportunity for monetary rewards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least 18 years of age;
- own a study-compatible smartphone (iPhone or Android device);
- report non-cancer related chronic pain (consistent daily pain) for 3 months or greater;
- able to provide informed consent for study participation;
- used prescription opioids in the past 30 days; and
Key exclusion criteria (3 listed)
- currently pregnant;
- presenting with language barriers, cognitive impairment, or serious medical or psychiatric illness that in the opinion of the Investigator would preclude them from providing informed consent or participating in the study; and
- visual impairment or motor impairment that would interfere with use of a smartphone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Self-Monitoring Surveys + Contingency ManagementAsked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys. | Behavioural | Daily Self-Monitoring Surveys + Contingency Management |
| Daily Self-Monitoring SurveysAsked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app. | Behavioural | Daily Self-Monitoring Surveys |
Primary outcome
Number of Daily Self-monitoring Surveys Completed
Time frame: 28-day daily survey period
Number of days daily surveys completed
Longest Period of Sustained Adherence to Daily Survey Completion
Time frame: 28-day daily survey period
Largest number of consecutive days wherein daily surveys were completed
2 secondary outcomes
Daily Survey Completion Time
Time frame: 28-day daily survey period
CM App Acceptability
Time frame: 28-day follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dace Svikis, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Self-Monitoring Surveys + Contingency Management and Daily Self-Monitoring Surveys in people with Pain, Chronic, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Daily Self-monitoring Surveys Completed (time frame: 28-day daily survey period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.